Identity
- Trade Name
- MTS FDA UDI
- Generic Name
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- MTS Anti-e (small e) (Monoclonal) Card FDA UDI
- Model / Reference
- MTS080312 FDA UDI
- Description
- MTS Anti-e (small e) (Monoclonal) Card FDA UDI
Identifiers
- Catalog Number
- MTS080312 FDA UDI
- Primary DI / UDI-DI
- 10758750005925 FDA UDI
- GMDN Term
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anti-E [RH005] red blood cell grouping IVD, antibody
Mts by Micro Typing Systems, Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- IH-Card Anti-e — Bio-Rad Medical Diagnostics GmbH
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- Seraclone® Anti-e (RH5) — Bio-Rad Medical Diagnostics GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Micro Typing Systems, Inc
Sources (1)
- FDA UDI 1425ccdb-8e8e-4cf7-94d7-3baadfa43de9 35 fields · synced May 30, 2026